FOR RELEASE ON |
23 June 2014 |
IP Group plc - Portfolio company Diurnal reports positive Phase 2 results
IP Group plc (LSE: IPO) ("IP Group" or "the Company" or "the Group"), the developer of intellectual property based businesses, is pleased to note that portfolio company Diurnal Limited ("Diurnal") has today announced positive results from a 6-month Phase 2 clinical study in 16 adults suffering from the rare disease Congenital Adrenal Hyperplasia ("CAH").
Diurnal, a spin-out company from the University of Sheffield in which IP Group holds a 41.8% undiluted beneficial interest, announced that its CATCH (Chronocort® As Treatment for Congenital Adrenal Hyperplasia) trial successfully met its primary endpoint. As well as demonstrating acceptable pharmacokinetics, Chronocort® provided significantcontrol of the disease as measured by 24-hr levels of the androgens, 17-hydroxyprogesterone (17OHP) and androstenedione (A4), all of which were brought into their optimal ranges after 6-months' treatment.
CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. CAH has been identified as an orphan disease in Europe where there are estimated to be approximately 30,000 sufferers, with a further 21,000 sufferers in the US. Current therapy for CAH - replacement of cortisol with synthetic steroids - is unable to simulate the natural circadian (24-hour) profile of cortisol release. Poor control of disease can result in precocious puberty in infants, virilisation and infertility, combined with fatigue and a poor quality of life, while overuse of steroid therapy can result in obesity, hypertension, diabetes, and osteoporosis.
Chronocort® is a patented, modified-release, oral formulation of hydrocortisone that allows for release of the hormone in a manner that mimics the natural circadian rhythm. This therapeutic approach has the potential to help patients suffering from diseases due to cortisol deficiency: congenital adrenal hyperplasia and adrenal insufficiency. Each of these diseases requires life-long treatment and Diurnal's novel approach to drug delivery has the potential to significantly improve patients' lives.Chronocort® has already received two related Orphan Drug designations from the European Medicines Agency, which afford ten years of market exclusivity after the grant of marketing authorisation in Europe.
Alan Aubrey, Chief Executive of IP Group, said: "This is an extremely important milestone for both Diurnal and IP Group. Diurnal, which became part of the IP Group portfolio through our recent acquisition of Fusion IP, exemplifies how we are supporting our later-stage companies as they progress towards commercialisation. Having achieved this Phase 2 result, Diurnal is now on the brink of a pivotal Phase 3 study that will take Chronocort to market."
Martin Whitaker, CEO of Diurnal, said: "These results, which show significantly improved control of the disease androgens, demonstrate a robust proof of concept for Chronocort® in the target patient population. Diurnal has already started Phase 3 activities as we seek to progress Chronocort® towards market authorisation. The CATCH results are a significant value point for the Company and have de-risked further development activities as Diurnal seeks to develop a high quality product for diseases of cortisol deficiency including Congenital Adrenal Hyperplasia."
The results of the CATCH trial were presented at the US ENDO Conference on 21st June 2014 by the National Institute on Health (Bethesda, US) where the trial was run under a Cooperative Research and Development Agreement (CRADA).
The full text of the announcement issued by Diurnal is copied below.
For more information, please contact:
IP Group plc |
www.ipgroupplc.com |
Alan Aubrey, Chief Executive Officer |
+44 (0) 20 7444 0050 |
Liz Vaughan-Adams, Communications |
+44 (0) 20 7444 0062 / +44 (0) 7979 853 802 [email protected] |
FTI Consulting |
|
John Dineen |
+44 (0) 20 7831 3113 |
Notes for editors
About IP Group
IP Group is a leading UK intellectual property ("IP") commercialisation company, developing technology innovations primarily from its research intensive partner universities. The Group offers more than traditional venture capital, providing its companies with access to business building expertise, networks, recruitment and business support.
The Company's portfolio comprises holdings in over 90 companies including Oxford Nanopore Technologies, the DNA sequencing development company, Revolymer, best known for its removable chewing gum and Xeros, which has received many accolades for its revolutionary clothes washing techniques with a much reduced requirement for water.
The portfolio includes early stage to mature businesses and has exposure to five main sectors - Energy & Renewables, Healthcare, Biotech, IT & Communications and Chemicals & Materials.
For more information, please visit our website at www.ipgroupplc.com.
Diurnal Reports Positive Results from a Phase 2 Study in Congenital Adrenal Hyperplasiapatients
Cardiff, UK - 23 June, 2014 - Diurnal Limited today announces positive results from its Phase 2 CATCH (Chronocort® As Treatment for Congenital Adrenal Hyperplasia) clinical study in 16 adults with the rare disease Congenital Adrenal Hyperplasia (CAH).
The trial successfully met its primary objective of fully characterising the pharmacokinetic profile of Chronocort® in adult subjects with congenital adrenal hyperplasia. The 24-hr Chronocort® pharmacokinetics in patients were comparable those in the Phase 1 clinical trial of dexamethasone suppressed healthy adult volunteers. The results show Chronocort® provides circadian levels of the stress hormone cortisol similar to the normal healthy population mimicking the overnight rise in cortisol levels such that patients wake with a normal cortisol level.
In addition, the secondary objective of examining the effect of Chronocort® on the biochemical efficacy markers of the disease showed significantcontrol of the 24-hr levels of the androgens, 17-hydroxyprogesterone (17OHP) and androstenedione (A4) which were brought into their optimal ranges after 6-months treatment with titrated Chronocort® compared to standard treatment.
Chronocort® was safe and well tolerated during the 6-month trial.
The results of the CATCH trial were presented at the US ENDO Conference on 21st June 2014 by the National Institute on Health (Bethesda, US) where the trial was run under a Cooperative Research and Development Agreement (CRADA).
About Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia is a condition characterised by deficiency in the stress hormone cortisol due to an inherited enzyme defect in the adrenal gland. Cortisol is an essential hormone in regulating metabolism and the response to stress. Cortisol levels are controlled by the central brain clock and build over night from 3am to peak in the morning and fall to low levels in the evening. In Congenital Adrenal Hyperplasia, the deficiency in cortisol results in the brain trying to stimulate the adrenal gland and a build-up in pre-cursor hormones that are androgens (testosterone like). This build-up in androgens occurs from 3am in the morning and lasts through the day. The excess androgens cause precocious puberty in boys and girls, virilisation in women and infertility in men and women. Thus, patients with Congenital Adrenal Hyperplasia have two problems; a deficiency in cortisol and an excess of androgens.
CAH has been identified as an orphan disease in Europe where there are estimated to be approximately 30,000 sufferers in Europe and a further 21,000 sufferers in the US. Current therapy for CAH involves replacing cortisol with one or a combination of the synthetic steroids; cortisone, hydrocortisone, prednisolone and dexamethasone. However, these steroid formulations are unable to simulate the cortisol rise over night and patients are either exposed to too little or too much steroid. Deficient steroid levels result in high androgens complicated by precocious puberty, virilisation and infertility combined with fatigue and a poor quality of life. Excess steroid levels result in obesity, hypertension, diabetes, and osteoporosis. Recent studies suggest that only a third of patients with Congenital Adrenal Hyperplasia have controlled disease and the other two thirds are exposed to either excess or deficient steroids. There is therefore an important unmet need for a steroid therapy that replaces the circadian rhythm of cortisol and improves the control of androgens in Congenital Adrenal Hyperplasia.
About Chronocort®
Chronocort® is a patented, modified-release, oral formulation of hydrocortisone that allows for release of the hormone into the body in a manner that mimics the natural circadian (24-hr) levels of natural hormone. This therapeutic approach has the potential to help patients suffering from diseases due to cortisol deficiency: congenital adrenal hyperplasia and adrenal insufficiency. Each of these diseases requires life-long treatment and Diurnal's novel approach to drug delivery has the potential to significantly improve patients' lives. Chronocort® already has received two related Orphan Drug designations from the European Medicines Agency, which afford ten years of market exclusivity after the grant of marketing authorisation in Europe.
Martin Whitaker, CEO of Diurnal, stated: "These results, which show significantly improved control of the disease androgens, demonstrate a robust proof of concept for Chronocort® in the target patient population. Diurnal has already started Phase 3 activities as we seek to progress Chronocort® towards market authorisation. The CATCH results are a significant value point for the Company and have de-risked further development activities as Diurnal seeks to develop a high quality product for diseases of cortisol deficiency including Congenital Adrenal Hyperplasia."
Melanie Goward, Deputy Fund Manager in Finance Wales' technology ventures team said: "We're delighted with the positive outcome of the Chronocort® CATCH Phase 2 trial as well as the progress Diurnal is making towards launching a marketed orphan drug product with the potential to treat the rare disease, CAH. It is now well-placed to capitalise on these results and to engage with pharmaceutical and biotechnology companies searching for acquisition and partnership opportunities. Diurnal is also currently recruiting additional clinical development roles based at its Welsh headquarters to underpin its continued expansion."
Please direct all enquiries to:
Martin Whitaker CEO Diurnal; [email protected] www.diurnal.co.uk
Helen Walker-Smith, Finance Wales; [email protected]
029 2033 8149
www.financewales.co.uk
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